Home / Recalls / Clinical Diagnostic Solutions / Z-0194-2013

Z-0194-2013 Class III Terminated

Recalled by Clinical Diagnostic Solutions — Plantation, FL

Recall Details

Product Type
Devices
Report Date
November 14, 2012
Initiation Date
August 4, 2010
Termination Date
August 14, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
690 packs

Product Description

Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

Reason for Recall

Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule

Distribution Pattern

Nationwide Distribution.

Code Information

Product part 501-607, Lot #1005-549

Other recalls by Clinical Diagnostic Solutions

  • Z-1001-2020 Class II — Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; O (January 2, 2020)
  • Z-1436-2014 Class II — Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for i (February 24, 2013)
  • Z-0189-2013 Class III — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to (March 24, 2011)
  • Z-0190-2013 Class III — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to (March 24, 2011)
  • Z-0191-2013 Class III — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to (March 24, 2011)
  • Z-0193-2013 Class III — Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control (August 4, 2010)